Next-Jen Biomed Ltd., which is in the process of merging St. Tech Medical, The developer of a unique technology for exhalation diagnostics, reports that St.-Tech informed the company that after analyzing hundreds of exhalation biopsies from corona patients and healthy volunteers, the identification based on the biomarkers mapped by St.-Tech, stands at a sensitivity higher than 91% and specificity ) Higher than 91.2%.
In doing so, the company crossed the threshold required for a diagnostic test with efficacy at least equivalent to the ‘gold standard’ test that exists today, which is a PCR test, for submission to FDA regulatory approval.
Saint-Tech also reports that it has developed a unique algorithm, which allows for an even higher level of sensitivity and specificity, which at this stage stands at about 98.0% for the identification of the corona virus.
St. Tech reported that after analyzing the chemical composition of hundreds of exhalation biopsies from corona patients and healthy volunteers (PCR negative), and after analyzing them, both using the company’s unique algorithms and using mathematical models accepted by regulatory authorities in Israel and around the world, the company was able to map several biomarkers. Uniquenesses that enable the identification of Covid-19 patients (corona patients) at different stages of the disease (asymptomatic and symptomatic patients).
The biomarkers identified in the mapping process are a scientific breakthrough and the basis for the construction of a “chemical fingerprint” that will be used to identify corona, corona mutations and immune status, by the company’s commercial system (VOX). The system is currently undergoing a large-scale validation trial at Shamir Hospital (Assaf Harofeh) and which is expected to be completed in about two months. Saint-Tech Medical is preparing to file a patent application for the biomarkers identified by it as soon as possible.
Next-Jen CEO, Yaniv Hebron: “We are pleased to report results that are a scientific breakthrough that demonstrate the great clinical potential, importance of the development of St. – Tech and the value that it has to bring to Next Jen after the merger. Based on these important results, we are preparing to apply for Ministry of Health approvals. In Israel and the US Food and Drug Administration for the widespread use of technology developed by Saint-Tech around the world.